The influence of different flow rates of intrathecal baclofen infusion on dystonia and pain in Complex Regional Pain Syndrome type 1
Completed
- Conditions
- dystonia of enlarged muscletone10028037
- Registration Number
- NL-OMON31522
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
•Patients must suffer from tonic or intermittent dystonia in one or more extremities.
•Patients have an implanted programmable pump (SynchroMed® pump, Medtronic, Minneapolis MN, USA, 40 mL reservoir) for continuous intrathecal drug administration.
•Patients have shown an insufficient response to intrathecal baclofen (ITB) at the usual flow rate, that is a <25% improvement on dystonia severity while ITB was administered to a level of at least 1000 µg/day or lower because of dose-limiting side effects.
•Patients must report spontaneous dystonia of at least 5 on a numeric rating scale (0 represents no dystonia, 10 represents worst imaginable dystonia).
Exclusion Criteria
Exclusion criteria are other causes of dystonia and pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcomes are severity of pain and dystonia using a NRS. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Efficacy as evaluated by dystonia severity (Burke-Fahn-Marsden scale),<br /><br>patient*s preference (PPQ), and global impression of improvement after each<br /><br>treatment (global impression scale).<br /><br>2. Safety of the procedure as evaluated by the occurrence of adverse events. </p><br>